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Key risk areas
As well as considering the research proposal and the answers to
the questions on the application form (and checking them against
the criteria on the checklist) the co-ordinator and/or research
approval group should also consider the following issues.
The vulnerability of the research participants
Some prospective participants including children, people with
learning difficulties or service users with mental health issues
may not be able to give informed consent. Before commencing any
research it is essential that consent is obtained from a
responsible person with the legal ability to give such consent on
the subject’s behalf.
The researcher’s experience
The level of experience of the researcher is likely to have a
bearing on the way in which research is carried out and the impact
on the participants. This may range from general inexperience, e.g.
being a student, to lacking any real knowledge of the subject
matter, to lack of experience of working with the client group
through to lack of knowledge of the best methods to use in the
research. It is essential to ascertain the level to which the
researcher’s qualifications and experience are relevant and
appropriate to the research area and methodology.
Research method and any additional issues this may raise
For example, research requiring participants to be interviewed
in their own homes means increased levels of disclosure of personal
information and potential risk.
Collection of sensitive information
Before approval is given for research involving the collection
of sensitive information, such as criminal records, psychiatric
history or health status, special consideration must be given to
whether the collection of this information is justified and if it
is justifiable, to what extent the research is in the interests of
the research subject?
Privacy and confidentiality
Are the proposed methods of ensuring anonymity and
confidentiality of participants adequate? Does the information
collection process conform to the Data Protection Act 1998
and local Caldicott Guardian standards?
Requirement for consent
All research requires an information sheet to be provided to
participants and a consent form to be completed before any
interviews can be carried out. It is important the research
proposal defines the potential benefits of the research, along with
how the necessary consent will be obtained.
Reluctant participants may still be willing to take part if they
feel the study has a wider benefit
If informed consent cannot be obtained, however, the participant
cannot be interviewed as part of the research.
Sensitivity of research
The actual subject matter for a proposed research project should
be considered carefully along with the professional experience and
background of the researcher. For example, research into
bereavement or sexuality is likely to require a greater level of
expertise and professional knowledge than research into
satisfaction around meals on wheels.
Where the proposed topic is sensitive, at the point of informed
consent participants should also be asked if they are prepared to
accept the possibility that distress may be caused and should be
reminded that they can choose not to take part in the study at any
stage. Any information given up to this stage should be
Potential need for planned follow-up support where
Where particularly sensitive areas are to be researched, the
need and capacity for follow up by both the researcher and the
social services department should be taken into account as this may
have resource implications, as well as personal consequences,
particularly for research participants.
Research may generate interest by the media, public concern,
political agendas and implications arising from the findings. Is
there the possibility that the findings will be misinterpreted or
misrepresented? Do the research timescales mean there is a danger
that a lack of time could lead to incomplete or inaccurate
findings? Hence the need to ensure that the timetable is realistic.
If the findings are unpalatable to certain stakeholders or liable
to be exaggerated to suit an agenda, how will that be dealt
Will the research involve only minimal and predictable risk to
the participants and/or the researcher and are the levels of risk
acceptable? Are there any health and safety issues and if so, is a
risk assessment necessary? Examples of when there may be health and
safety issues could include research where interviews are conducted
by a single researcher in isolation or when interviews are planned
to take place in participants’ homes in the evenings.